| Essential Functions: Significant emphasis on customer service and managing processes related to human research participant protections, submissions facilitation and regulatory compliance. Manage and process all PH1 submissions and coordinate the review process; coordinate and attend IRB meetings; capture the IRB's revision requirements, committee decisions and activities according to policy, guidelines and regulations. Reviews investigators' responses; elicits reviewers' assistance or refers to Chair or appropriate person for decisions; provide all documents and generates minutes based on established guidelines, policies, and regulations; and directs unresolved issues to the Associate Director.Assists researchers and their staff with questions including submissions and understanding the committee's decisions and revision requirements.Serves as a technical resource regarding interpreting and applying all research regulations, Federal and State regulations, and policies and procedures governing the participation of human participants in research for researchers, IRB members, staff, and Study Coordinators. Shares best practices and, through excellent communication and teaching skills, help the investigators and their staff anticipate ethical issues and address these issues in their submissions. Reviews PH1 Unexpected Problem Reports and directs to UP Reviewer or appropriate person. Provides procedural guidance to investigators when adverse events or violation is minor to ensure policy and regulatory compliance is maintained. Create memos associated with the Unexpected Problem Reports.Serve as a pre-reviewer of all Phase I submissions to determine completeness and compliance with all regulations and institutional policies. Reviews and proposes revisions to Phase I research consent forms and Health Information Portability and Accountability Act Authorization forms to ensure readability for lay individuals. Ensures that all electronic materials are posted and available for review by IRB members in a timely fashion. Serve as an exempt medical protocol Reviewer for submissions for all medical IRB committees. Process submissions, creating memos and provide the final review, including the approval or revisions. Prepare for internal and external audits. Ensure that committee activities, minutes, and all records are compliant with all research regulations.Attends other IRB meetings as requested to perform duties as needed (for example: vote counter, taking attendance, running the projector as needed, assisting with covering RCA duties when this is a need, etc.). Conducts trainings for research community on relevant IRB policies and procedures and regulations. Refers individuals needing general and additional education to the IRB Education Coordinator. Participates in and develops best-practices for continuous quality improvement of job duty areas. Assists with the development and revising of IRB forms, manuals, policies, website and standard operating procedures. Informs Associate Director of issues raised by the IRB or investigators; performs other duties and special projects as assigned. Assists with special projects, matching of scanned files, and other IRB-related matters.|
Qualifications: Bachelor's degree in a field relevant to the job duties.Attention to detail, good organization skills and the ability to continuously multitask in a fast-paced work environment are required and are essential to succeed in this position.Ability to establish and meet deadlines, work under extreme pressure and function independently.Ability to use and willingness to learn our computer software systems and detailed regulations from a variety of regulatory compliance bodies (FDA, OHRP, DoD, etc.). Work is computer-based.Excellent writing and typing skills are essential to succeed in this position. Excellent customer service and communication skills to work effectively with faculty, staff, students, and research representatives from a variety of diverse backgrounds are required and are essential to succeed in this position.Strong analytical, decision making, coordinating and problem solving skills are required.